It’s hard to imagine this today, but place yourself in the role of a medical student in 1846 in Vienna. Much like medical students today, you’re hands deep in a cadaver, learning about the anatomy, structures, and physiology of your future patients. Unlike today, however, you’re not wearing gloves. And unlike today, at the end of your class in the mortuary, you walk straight into the maternal clinic where you start performing examinations on women in labour – again, without gloves, and with your hands unwashed.
Today, it seems absurd to imagine a dirty hospital environment where doctors don’t wash their hands. In 1847 Vienna, however, that was not the case. The primary obstetrics clinic at Vienna General Hospital had such an astonishing maternal mortality rate of 18.47 per cent that women would beg to not be admitted there, and some even tried to have their baby on the street instead. Only when a doctor nicked their hand on a scalpel and died of a disease resembling puerperal fever – what we call maternal sepsis today – was handwashing trialled. Dr Ingnaz Semmelweis instituted a policy requiring hands to be washed with chlorinated lime (a form of bleach) between autopsies and births. In two months, the death rate went from 18.47 per cent to 1.27 per cent. Going from 1 in every 5 patients dying to 1 in 100 was obvious to anyone watching.
You would think that this is a perfect example of a medical innovation: simple to implement, backed by clear evidence, and highly effective. One would think that it would have been rapidly implemented, rolled out across wards within days. The tragedy, however, is that Semmelweis was ridiculed, his theories rejected. Semmelweis was shunned by the medical fraternity to the point of a mental breakdown and was committed to a mental institution. It took another 20 years before pre-surgical handwashing started. Incredibly, it was not until the 1980s that hand hygiene was officially incorporated into American health care with national hand-washing guidelines – more than a century later.
Why is it that some medical innovations have seen widespread adoption despite known limitations, while other well-evidenced and effective innovations take decades to become clinical practice, if ever?
As both a practising doctor, and a successful medtech founder, there are three main factors that drive uptake that need to be met for acceptance and adoption. Firstly, we improved clinical outcomes (which all innovators understand), but secondly, two more that are often left as an afterthought: workflow and accessibility.
Improved Clinical Outcomes
In philosophy, we have the term “omission bias”; namely, that harm from inaction is deemed less culpable than the same degree of harm from action. To rephrase this bluntly in healthcare terms, our institutions call the same number of patients dying as last year the “standard of care”, while the fewer who die by an untried innovation are seen as deaths they might be blamed for. Therefore, to truly drive healthcare change through the healthcare business, there is a large hurdle for innovators to overcome: not just credibly demonstrating outcomes that are better, but outcomes that are substantially so.
Semmelweis showed that hand washing could reduce mortality rates. He was also able to repeat the experiment and demonstrate the results. The magnitude of improvement was also huge. Reducing mortality from ~18 per cent to ~1 per cent is a larger impact than most new oncology drugs have today. Semmelweis had the statistics; he had the credible demonstration of improved outcomes, and this improvement was more than substantial.
Yet, Semmelweis was hesitant to publish his results. It was his students who first presented their findings and when backlash and misinterpretations came (as they do), they struggled to contend with the hierarchy. For a long time, his work was only discovered through second-hand reports. When he finally started presenting his findings, they were rejected by many in the medical community.
The problem here is that the hurdle was huge: the disease transmission vector that could be broken by hand-washing was the doctors themselves. Those who needed to be convinced to implement the change also needed to believe that their current practices were the problem. Semmelweis further alienated obstetricians and critics by lashing out at them, instead of working with them.
Semmelweis is truly the pathognomonic case of outcome improvement not being enough: the establishment accepted an 18 per cent death rate as the standard of care but treated his proposed intervention as an aspersion on their medical skills.
Workflow
One would still think, however, that there would be some doctors willing to try something as simple as washing their hands? Today, when I think of a hospital ward, I know there will be sinks every 10-15m along the walls between rooms, and hand sanitiser dispensers everywhere – outside every room, on the end of every bed, and on the wall of every room. Imagine a world not only prior to alcohol hand sanitiser but one prior to handwashing being common. Semmelweis didn’t even have indoor plumbing or running water but rather washed his hands in basins of poured water. You had to fetch water and take time out of your day to do so.
This was a huge challenge for Semmelweis. Having doctors wash their hands did not fit in their existing workflow. Moving between wards without stopping was effective. Going via a place where they had to stop to wash their hands broke the natural flow of their day. This problem still holds true today. A hospital is an incredibly busy environment. Doctors and nurses have ways of working that may seem absurd to an outsider but have been created over many decades for a reason. Asking someone to change the way that they work every day is a big ask.
Some innovations, however, fit so perfectly into a hospital workflow that their adoption happens before even showing an outcome benefit: workflow matters so much that it can incorrectly override the requirement to show a strong clinical benefit. Take, for instance, the pulmonary artery catheter developed by Swan and Ganz in 1970. At a time when intensivists had almost no tools for hemodynamic monitoring, this was revolutionary. It gave them a dashboard with various numbers that fit into their existing clinical decision workflow. It was easy for nurses to check the numbers during morning rounds and report them back. This ease of monitoring and workflow enhancement resulted in up to 40 per cent of ICU patients undergoing pulmonary artery catheterisation in the 1980s, even though the safety, accuracy, and benefits of the device had never been established but now are known to show no benefit, higher costs, and the risk of harm.
To any medical innovators building tools for hospitals, I strongly urge you to think about workflows from Day One. Become clear on exactly what you need each clinical user to do and how that is different from the way things are done today. Engage key voices in the space early to ensure you have internal champions. Determine whose workflow your device fits within, and what the impacts on their day-to-day will be.
Accessibility
Since the 1980s, hand-washing has caught on. We have the five moments of hand-hygiene – washing or sanitising our hands multiple times while seeing each patient during a ward round. We now have indoor plumbing and running water, and alcohol hand-sanitiser, first available in the 1980s in America, is everywhere in a modern hospital. With these changes to the accessibility of handwashing, it is now standard practice. And while it seems strange to say so, just like handwashing: if your solution is expensive, incredibly complex, or requires education and specialised training, you can expect adoption to be slow.
Accessibility harms the uptake of other good clinical practice improvements. Take vancomycin therapeutic drug monitoring, for example. Guidelines and medical societies universally recommend Area Under the Curve (AUC) dosing for vancomycin, the most used IV antibiotic in the USA. Research demonstrates that AUC dosing results in fewer incidences of acute kidney injury than trough-based dosing, which hospitals currently use. AUC dosing is challenging but Bayesian monitoring was developed to address this challenge. Unfortunately, Bayesian adoption has been limited and slow, even though it has proven to be effective.
While Bayesian monitoring has ample clinical outcome improvement, its accessibility is problematic. The tool is expensive, hospitals are reluctant to recommend use and manage maintenance, it sits outside the standard ward-round workflow of a medical team, and finally it still requires specialist training. The tool that overcomes these limitations while delivering outcomes will ultimately make AUC dosing a more common practice. Wearables, such as the continuous molecular monitor Nutromics is building for vancomycin TDM, are one such contender.
Innovators need to make their solutions easily accessible to enable widespread adoption. This may be through cost, availability, training, knowledge of use, or a combination of all of the above. Crucial to this is the development of a collaborative strategy, bringing together ordinarily siloed arms of the business such as marketing, clinical, and reimbursement.
Human beings are natural innovators, but there is a catch, as Semmelweis discovered: innovation without adoption does not actually result in lasting improvement. This is why I want to urge medical innovators to master the art of adoption. It’s not enough to deliver improved outcomes. In an environment as busy and unusual as a hospital, your innovation must fit into the workflow and be accessible to those who need it. By not just focusing on our clinical statistics, but on who and how will use a device, we can drive adoption and drive a larger impact on the health of our friends, family, and society as a whole.
